Note: This document contains side effect information about epoetin alfa. Some dosage forms listed on this page may not apply to the brand name Procrit.
Summary
Common side effects of Procrit include: upper respiratory tract infection, arthralgia, decreased serum iron, diarrhea, edema, fever, low serum ferritin, paresthesia, respiratory congestion, skin rash, tachycardia, cough, dyspnea, headache, nausea, signs and symptoms of injection site, and vomiting. Other side effects include: chest pain. Continue reading for a comprehensive list of adverse effects.
Applies to epoetin alfa: injection solution.
Warning
Injection route (Solution)
ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.Chronic Kidney Disease:In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level greater than 11 g/dL.No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.Use the lowest epoetin alfa-epbx dose sufficient to reduce the need for red blood cell (RBC) transfusions.Cancer:ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.Use ESAs only for anemia from myelosuppressive chemotherapy.ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.Discontinue following the completion of a chemotherapy course.Perisurgery:Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended.
Serious side effects of Procrit
Along with its needed effects, epoetin alfa (the active ingredient contained in Procrit) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking epoetin alfa:
More common
- Black, tarry stools
- blurred vision
- body aches or pain
- bone pain
- chest pain
- chills
- cough
- dizziness
- dry mouth
- ear congestion
- fever
- flushed, dry skin
- fruit-like breath odor
- headache
- increased hunger
- increased thirst
- increased urination
- itching, skin rash
- loss of voice
- nausea
- nervousness
- pain, redness, or swelling in the arm or leg
- painful or difficult urination
- pounding in the ears
- runny or stuffy nose
- slow or fast heartbeat
- sneezing
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain
- swollen glands
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
- trouble breathing
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Less common
- Anxiety
- decreased urine
- difficulty swallowing
- fainting
- irregular heartbeat
- loss of appetite
- mood changes
- muscle pain or cramps
- numbness or tingling in the hands, feet, or lips
- seizures
- swelling
Incidence not known
- Blistering, peeling, or loosening of the skin
- dark urine
- diarrhea
- fluid-filled skin blisters
- hives
- joint pain
- light-colored stools
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- sensitivity to the sun
- skin thinness
- tightness in the chest
- yellow eyes or skin
Other side effects of Procrit
Some side effects of epoetin alfa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Decreased weight
- difficulty in moving
- injection site irritation or pain
- muscle spasm or stiffness
- swelling or inflammation of the mouth
- swollen joints
- trouble sleeping
Less common
- Discouragement
- feeling sad or empty
- irritability
- loss of interest or pleasure
- trouble concentrating
For Healthcare Professionals
Applies to epoetin alfa: injectable solution.
General
The most common adverse reaction was dose-dependent increase in blood pressure or aggravation of existing hypertension.[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 56%), diarrhea (up to 30%), vomiting (up to 28%), stomatitis (10%)
Common (1% to 10%): Dysphagia
Frequency not reported: Vomiting[Ref]
Other
Very common (10% or more): Pyrexia (up to 42%)
Common (1% to 10%): Chills, influenza-like illness, peripheral edema, artificial kidney clotting during dialysis, edema[Ref]
Nervous system
Very common (10% or more): Headache (up to 34%)
Common (1% to 10%): Convulsion, dizziness
Frequency not reported: Cerebrovascular accident, transient ischemic attack[Ref]
Cardiovascular
Very common (10% or more): Hypertension (up to 33%), embolism and thrombosis (up to 15%)
Common (1% to 10%): Deep vein thrombosis, thrombosis
Uncommon (0.1% to 1%): Myocardial infarction
Frequency not reported: Blood pressure increased, aneurysm[Ref]
Respiratory
Very common (10% or more): Cough (up to 26%)
Common (1% to 10%): Respiratory tract congestion, upper respiratory tract infection, pulmonary embolism[Ref]
Dermatologic
Very common (10% or more): Rash (up to 25%), pruritus (up to 21%)
Common (1% to 10%): Urticaria
Uncommon (0.1% to 1%): Erythema
Frequency not reported: Angioedema
Postmarketing reports: Severe cutaneous reactions[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (up to 24%), pain in extremity (up to 15%), myalgia (up to 10%)
Common (1% to 10%): Bone pain, muscle spasm
Frequency not reported: Porphyria[Ref]
Local
Very common (10% or more): Injection site reaction (up to 18%), injection site pain (up to 13%)
Common (1% to 10%): Vascular access thrombosis[Ref]
Metabolic
Very common (10% or more): Hyperkalemia (up to 10%)
Common (1% to 10%): Weight decrease, hyperglycemia, hypokalemia[Ref]
Psychiatric
Common (1% to 10%): Insomnia, depression[Ref]
Hematologic
Common (1% to 10%): Leukopenia
Postmarketing reports: Erythropoietin antibody-mediated pure red cell aplasia, thrombocytopenia[Ref]
Immunologic
Frequency not reported: Anaphylactic reaction, hypersensitivity
Postmarketing reports: Serious allergic reaction[Ref]